Observing the effects of high-intensity therapy in newly diagnosed multiple myeloma patients with persistent minimal residual disease

A Perspective Study of the MRD-tailored Therapy in Patients With Newly Diagnosed Multiple Myeloma With Persistent Minimal Residual Disease After Initial Treatment

This study is testing whether switching newly diagnosed multiple myeloma patients who still have minimal residual disease to a stronger treatment can help them live longer and feel better compared to those who no longer have the disease after initial treatment.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT06109233 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the conversion rates of minimal residual disease (MRD) and its impact on survival in patients with newly diagnosed multiple myeloma who remain MRD positive after initial treatment. Participants will be switched to high-intensity therapy, and their outcomes will be compared to those who achieved MRD negativity after the same treatment. The study will assess progression-free survival and overall survival rates, providing insights into the potential benefits of intensified treatment for this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed symptomatic multiple myeloma who have shown a partial response or better to prior treatment.

Not a fit: Patients who do not have newly diagnosed multiple myeloma or those who have not responded to initial treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates for patients with newly diagnosed multiple myeloma who have persistent MRD positivity.

How similar studies have performed: Other studies have explored MRD-tailored therapies in multiple myeloma, showing promising results, but this specific approach is still being evaluated.

Eligibility criteria

Inclusion Criteria:

1. Subject must be at least 18 years of age.
2. Subject must have documented newly diagnosed symptomatic multiple myeloma as defined by 2014 International Myeloma Working Group criteria.
3. Subject must have achieved a response (partial response \[PR\] or better based on investigator's determination of response by the IMWG criteria) to at one prior regimen.
4. Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. Contraception must begin 4 weeks prior to dosing and continue until at least 3 months after receiving the last dose of the study drug. A woman of childbearing potential must have a negative serum or urine pregnancy tests at screening within 14 days prior to randomization.
5. Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

1. Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma. Monoclonal gammopathy of undetermined significance is defined by presence of serum M-protein \<3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein; and (if determined) proportion of plasma cells in the bone marrow of 10% or less. Smoldering multiple myeloma is defined as asymptomatic multiple myeloma with absence of related organ or tissue impairment or end-organ damage.
2. Relapsed and refractory myeloma：Relapsed and refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course.
3. Primary refractory myeloma：Primary refractory myeloma is defined as disease that is nonresponsive in patients who have never achieved a minimal response or better with any therapy.
4. Subject is known or suspected of not being able to comply with the study protocol。 Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.

Where this trial is running

Changchun, Jilin

• The First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Conditions Multiple Myeloma; Minimal Residual Disease; MRD-tailored therapy; MRD status; MRD-negative rates; Survival